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U.S. Department of Health and Human Services

Class 2 Device Recall SURFIX Fixed Angle Locking Screw

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  Class 2 Device Recall SURFIX Fixed Angle Locking Screw see related information
Date Initiated by Firm March 28, 2014
Date Posted June 02, 2014
Recall Status1 Terminated 3 on April 18, 2016
Recall Number Z-1697-2014
Recall Event ID 68284
510(K)Number K073375  
Product Classification Screw, fixation, bone - Product Code HWC
Product Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm (catalog number 285330S). Screws are provided in different diameters and lengths and are used to anchor various sizes and shapes of bone fixation plates when treating bone fractures or reconstruction of the ankle, foot or hand.
Code Information SURFIX 3.5 mm D X 22 mm L /Cat No 285322S Lot no. F6S6;  SURFIX 3.5 mm D X 30 mm L /Cat. No. 285330S Lot no. F6ZL
Recalling Firm/
Manufacturer		 Integra LifeSciences Corporation
105 Morgan Ln
Plainsboro NJ 08536-3339
For Additional Information Contact
855-532-1723
Manufacturer Reason
for Recall		 New Deal has identified through a complaint report that some 3.5 mm Diameter x 22 mm Length Surfix screws in Lot no. F626 (Catalogue No. 285322S) have been packaged and labeled as 3.5mm Diameter x 30 mm Length Surfix screws (Catalogue No. 285330S).
FDA Determined
Cause 2		 Package design/selection
Action Integra issued an Urgent Voluntary Medical Device Recall letter dated March 28, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory for affected product, immediately stopo using or distributing them. Customers were asked to complete the Acknowledgement Form and return by email or fax as indicated on the form. When the form is received customer service will contact customers to provide an RMA number and directions to return the affected products. Customers with questions were instructed to call 1-855-532-1723. For questions regarding this recall call 609-275-2700.
Quantity in Commerce 417 units
Distribution Worldwide Distribution - USA including AR, CA, NC, TX and Internationally to Austria, Chile, Denmark, Finland, France, Germany, Greece, Ireland, Italy ,Lebanon, Portugal, Russia, South Africa, Spain, Switzerland, United Arab Emirates, and United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = NEWDEAL SAS
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